Association of Haptoglobin 2-2 With Postoperative Delirium

NCT03392480 | Withdrawn

• 1 other identifier: S2017-096-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• Postoperative delirium incidence

  The incidence of delirium as assessed by intensive care unit-confusion assessment method will be determined.

  From day 0 to up to 7 days after the surgery

• Postoperative delirium duration

  The duration of delirium as assessed by intensive care unit-confusion assessment method will be determined.

  From day 0 to up to 7 days after the surgery

Secondary Outcomes (2)

• Oxidative stress level

  Day 0 to day 2 after the surgery

• Inflammation level

  Day 0 to day 2 after the surgery

Study Arms (4)

Adult non-haptoglobin 2-2 group

Patients are 45 to 65 years old.

Adult haptoglobin 2-2 group

Patients are 45 to 65 years old.

Elder non-haptoglobin 2-2 group

Patients are elder than 65 years.

Elder haptoglobin 2-2 group

Patients are elder than 65 years.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the inclusive criteria will be screened as possible candidates.

You may qualify if:

• American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery)
• No psychological and psychiatric history and presentation before surgery
• No major organ dysfunction or failure

You may not qualify if:

• Anemia (hemoglobin \< 100 g/l) preoperatively.
• Requires \> 4 units of allogeneic red blood cell transfusion during the surgery
• Can not cooperate with the study
• History of bleeding
• BMI \< 18 or \> 30
• History of hemoglobin metabolism disorder

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (8)

Beijing Jishuitan hospital

Beijing, 100009, China

Location

Chinese PLA general hospital

Beijing, 100853, China

Location

Xinqiao hospital, Army military medical university

Chongqing, 400037, China

Location

Daping Hospital, Army Military Medical University

Chongqing, 400042, China

Location

the First Affiliated Hospital of Southern Medical University

Guangzhou, 510515, China

Location

Third affiliated hospital of southern medical university

Guangzhou, 510630, China

Location

shanghai Changzheng hospital, Naval Military Medical University

Shanghai, 200433, China

Location

Shenyang general hospital of military region

Shenyang, 110015, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum or plasma

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 8, 2018
• Study Start: December 20, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)